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Sponsored by: |
Pfizer |
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Information provided by: | Pfizer |
ClinicalTrials.gov Identifier: | NCT00282932 |
An interventional active/placebo double blinded parallel randomized controlled study in which at 12 weeks of treatment, the primary endpoint of patient perception of bladder condition is measured along with associated safety and other secondary endpoints like bladder diary endpoints, quality of life and patient treatment satisfaction. Patients included in the study must have symptoms of OAB (frequency of at least 8 per day and Urgency of at least
1 episode per day confirmed by bladder diary). Patients are not eligible to enroll in the study if they have/had significant hepatic or renal disease, history of radiation treatment.
Condition | Intervention | Phase |
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Overactive Bladder (OAB) |
Drug: Detrol LA |
Phase IV |
Study Type: | Interventional |
Study Design: | Treatment, Randomized, Double-Blind, Placebo Control, Parallel Assignment, Safety/Efficacy Study |
Official Title: | A Randomized, Double Blind, Placebo Controlled Detrol LA "Add-On" To Alpha-Blocker Study In Men With Persistent Overactive Bladder Symptoms Of Urinary Frequency And Urgency With/Without Urgency Incontinence After Previous Monotherapy With Alpha Blocker. |
Estimated Enrollment: | 600 |
Study Start Date: | January 2006 |
Ages Eligible for Study: | 40 Years and older |
Genders Eligible for Study: | Male |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
Study Director: | Pfizer CT.gov Call Center | Pfizer |
Study ID Numbers: | A6121127 |
Study First Received: | January 26, 2006 |
Last Updated: | September 5, 2007 |
ClinicalTrials.gov Identifier: | NCT00282932 History of Changes |
Health Authority: | United States: Food and Drug Administration |
Muscarinic Antagonists Signs and Symptoms Urinary Bladder, Overactive Neurotransmitter Agents Cystocele Cholinergic Antagonists |
Urologic Diseases Urinary Bladder Diseases Urinary Incontinence Adrenergic alpha-Antagonists Cholinergic Agents Tolterodine |
Urinary Bladder, Overactive Neurotransmitter Agents Cholinergic Antagonists Molecular Mechanisms of Pharmacological Action Urinary Bladder Diseases Physiological Effects of Drugs Cholinergic Agents |
Pharmacologic Actions Muscarinic Antagonists Urological Manifestations Signs and Symptoms Urologic Diseases Tolterodine |